Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis

Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)

This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 31 participating pediatric healthcare systems. This open label study will be conducted in the setting of routine clinical care and will compare the risk and timing of flare (Aim 1) and patients' lived experiences (Aim 2) across three arms.

This project is a prospective, 12-month pragmatic randomized trial embedded within routine clinical care. Children with spondyloarthritis who have maintained inactive disease on a clinically prescribed standard dosing of a TNFi for 6 months or longer will be eligible for enrollment. Children will be randomized to one of the following alternative approaches: continued fixed standard dosing (arm 1), fixed longer dosing intervals of TNFi (arm 2), or stopping TNFi (arm 3). The recommended visit frequency is every 3 months through the study endpoint at 12 months. After subjects have followed their treatment assignment for 12 months, those who have not flared may modify their treatment regimen as per shared decision making between themselves and the treating physician. All participants will be monitored for 24 additional months for long-term outcomes after the intervention period.

Inclusion Criteria:

1. Males or females age 8 to 21 years

2. Juvenile SpA diagnosis:

   • Symptom onset before their 16th birthday:

   o International League of Associations for Rheumatology (ILAR) criteria for juvenile idiopathic arthritis enthesitis-related arthritis subtype

   OR;

   • Symptom onset before their 18th birthday:

   o Pediatric Rheumatology International Trials Organization (PRINTO) revision of the ILAR criteria enthesitis spondylitis-related JIA

   • Peripheral arthritis and enthesitis, or
   • Arthritis or enthesitis, plus ≥3 months of inflammatory back pain and sacroiliitis on imaging, or
   • Arthritis or enthesitis plus 2 of the following: (1) sacroiliac joint tenderness; (2) inflammatory back pain; (3) presence of HLA-B27 antigen; (4) acute (symptomatic) anterior uveitis; and (5) history of a SpA in a first-degree relative.
   • If peripheral arthritis is present, it should persist for at least 6 weeks.

3. Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab, or TNFi biosimilar) at standard doses

4. Have reached a clinically inactive disease state for a minimum of six months, as determined by treating physician

5. English speaking or Spanish speaking

6. Subject's treating physician recommended that he/she is a good candidate to participate in the study, which may include a modified therapy

7. Interested and willing to de-escalate TNFi therapy

Exclusion Criteria:

1) History of inflammatory bowel disease, history of uveitis that was not adequately controlled with localized ophthalmic treatment or psoriasis that pre-dates the start of TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control